MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC T2 SPINAL SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	9391316
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	01/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Adverse outcome: others: excessive bleeding.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient presented with kyphosis and t10 vertebral body fracture; and underwent posterior fixation at t7-l3 after t10 vertebral column resection (vcr).Intra-op, after vcr was performed at t10 and cylinder of 13mm was placed at t2, x-ray (taken at the time of posterior fixation) revealed that the cage did not connect with the endplate of t9.The cranial side of the cage had deviated towards the anterior side of the t9 vertebral body and bleeding occurred.Since the image had not been confirmed when placing the cage, it was considered that there was a high possibility that the initial placing position was originally at the anterior side.Because of a large amount of bleeding, the surgeon decided to give up doing the operation such as re-placement of the cage, and wound closure was performed after finishing the posterior fixation.The end cap was not used.It was said that the cage seemed to be not contracted.The patient's condition was not confirmed.There was delay of more than 60 minutes in overall procedure.The assistant surgeon considered that it was not an injury to the blood vessels etc.

• Brand Name: T2 SPINAL SYSTEM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 9742945
• Report Number: 1030489-2020-00190
• Device Sequence Number: 13946567
• Product Code: MQP
• UDI-Device Identifier: 00613994676511
• UDI-Public: 00613994676511
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9391316
• Device Lot Number: UM16B001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR